Lumoxiti (moxetumomab pasudotox) / AstraZeneca 
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 29 Diseases   1 Trial   1 Trial   377 News 


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  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    Review, Journal:  Moxetumomab Pasudotox in Hairy Cell Leukaemia: A Profile of Its Use. (Pubmed Central) -  Sep 2, 2021   
    Moxetumomab pasudotox had a generally manageable tolerability profile; the most common treatment-related adverse events (AEs) included nausea, peripheral oedema, headache and pyrexia. AEs of special interest (including haemolytic uraemic syndrome and capillary leak syndrome) were generally manageable and reversible with monitoring and supportive care.
  • ||||||||||  cladribine / Generic mfg.
    Review, Journal:  Hairy Cell Leukaemia. (Pubmed Central) -  Aug 20, 2021   
    HCLv has a worse prognosis with median overall survival (OS), only 7-9 years, despite the combination of PNA/rituximab improving front-line response. Moxetumomab or ibrutinib may be a viable treatment but lacks substantial evidence.
  • ||||||||||  cladribine / Generic mfg.
    Biomarker, Clinical, Review, Journal:  Hairy cell leukemia: What are the best treatment options for relapsed or refractory patients? (Pubmed Central) -  Jul 16, 2021   
    We will discuss in patients with relapsed/refractory hairy cell leukemia the needs for personalized medicine and the advantages and disadvantages of each treatment modality. The good prognosis for LT requires treatments that are not immunosuppressive, non-myelotoxic, and do not increase the risk of secondary cancers.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Zelboraf (vemurafenib) / Roche
    Clinical, Journal:  Vemurafenib and Rituximab in Patients with Hairy Cell Leukemia Previously Treated with Moxetumomab Pasudotox. (Pubmed Central) -  Jul 4, 2021   
    Two patients who had relapsed after vemurafenib and rituximab derived meaningful clinical benefit from retreatment with the same agents, but eventually relapsed again and started indefinite therapy with dabrafenib and trametinib leading to normalization of the blood counts (despite heavy bone marrow infiltration in the only patient so far evaluable in that regard). The outcomes of these cases indicate that novel targeted agents and, in particular, vemurafenib, combined with rituximab, improve the prognosis of HCL patients, even those heavily pretreated with PNAs and moxetumomab pasudotox.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    Journal:  Deamidation in Moxetumomab Pasudotox Leading to Conformational Change and Immunotoxin Activity Loss. (Pubmed Central) -  Jun 22, 2021   
    Here we describe the characterization of the deamidation variant with differential scanning calorimetry and hydrogen-deuterium exchange mass spectrometry, which revealed that the Asn-358 deamidation caused the conformational changes in the catalytic domain of the PE38 region. These results provide an explanation for why the deamidation affected the biological activity of moxetumomab pasudotox and suggest the approach that can be used for process control to ensure product quality and process consistency.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Zelboraf (vemurafenib) / Roche
    Journal:  Hairy Cell Leukaemia: From Hairy Beginnings to a BRAF New World. (Pubmed Central) -  Jun 16, 2021   
    This article covers some of the highlights from the last 6 decades that have led to our current understanding of this fascinating leukaemia - from elucidation of its B-cell origin to discovery of the almost universal occurrence of the BRAF V600E mutation; from the initial successes reported with splenectomy to the more recent development of targeted therapies such as Vemurafenib and Moxetumomab Pasudotox. It also pays tribute to some of the outstanding research in this field focusing particularly on the significant contributions made by the clinical and scientific community in the UK.
  • ||||||||||  Journal:  Treatment of hairy cell leukemia. (Pubmed Central) -  Jun 3, 2021   
    High-risk disease including HCL variant and IGHV4-34+ unmutated HCL require further investigation. (197 words).
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    Review, Journal:  Development of Glypican-3 Targeting Immunotoxins for the Treatment of Liver Cancer: An Update. (Pubmed Central) -  Apr 13, 2021   
    The U.S. Food and Drug Administration (FDA) recently approved Lumoxiti, a CD22-targeting immunotoxin, as a treatment for patients with hairy cell leukemia...However, concerns have been raised about the use of immunotoxins, including their high immunogenicity and short half-life, in particular for treating solid tumors such as liver cancer. This review provides an overview of recent efforts to develop a glypican-3 (GPC3) targeting immunotoxin for treating HCC, including strategies to deimmunize immunotoxins by removing B- or T-cell epitopes on the bacterial toxin and to improve the serum half-life of immunotoxins by incorporating an albumin binding domain.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, LMB-100 / National Cancer Institute, Roche
    Review, Journal:  Immunogenicity of Immunotoxins Containing Pseudomonas Exotoxin A: Causes, Consequences, and Mitigation. (Pubmed Central) -  Apr 10, 2021   
    Moxetumomab Pasudotox (Lumoxiti) contains an anti-CD22 Fv and a 38 kDa portion of PE...LMB-100 is a de-immunized variant of the toxin with a humanized antibody that targets mesothelin and a PE toxin that was rationally designed for diminished reactivity with antibodies and B cell receptors...Here we review the immunogenicity of the original and de-immunized PE immunotoxins in mice and patients, the development of anti-drug antibodies (ADAs), their impact on drug availability and their effect on clinical efficacy. Efforts to mitigate the immunogenicity of immunotoxins and its impact on immunogenicity will be described including rational design to identify, remove, or suppress B cell or T cell epitopes, and combination of immunotoxins with immune modulating drugs.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    [VIRTUAL] Development of Recombinant Immunotoxin for B-Cell Leukemia () -  Apr 4, 2021 - Abstract #PEGS2021PEGS_113;    
    Recombinant immunotoxin BL22 targeting CD22 achieved CRs as a single agent in chemoresistant HCL and an improved version Moxetumomab Pasudotox (Moxe) was FDA approved for relapsed/refractory HCL. Current efforts to improve the activity of Moxe in HCL include combination with anti-CD20 Mab to prevent immunogenicity and improve cytotoxicity.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Elzonris (tagraxofusp) / Menarini, Ontak (denileukin diftitox) / Eisai, Dr. Reddy’s, TSD Japan
    Review, Journal:  Critical issues in the development of immunotoxins for anticancer therapy. (Pubmed Central) -  Mar 26, 2021   
    The issues include off-target and on-target toxicities, immunogenicity, human cytotoxic proteins, antigen target selection, cytosolic delivery efficacy, solid-tumor targeting, and developability. To realize the therapeutic promise of ITs, novel strategies for safe and effective cytosolic delivery into designated tumors, including solid tumors, are urgently needed.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  Development of Recombinant Immunotoxins for Hairy Cell Leukemia. (Pubmed Central) -  Feb 18, 2021   
    A phase 3 trial met its endpoint of durable CR with acceptable toxicity, leading to FDA approval of Moxe for relapsed/refractory HCL, under the name Lumoxiti. Moxe combined with rituximab is currently being evaluated in relapsed/refractory HCL to improve the rate of MRD-free CR.
  • ||||||||||  Leustatin (cladribine) / J&J, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Hairy Cell Leukemia Variant - Current Approach () -  Jan 22, 2021 - Abstract #VLML2021VLML_34;    
    Novel agents like ibrutinib are also considered for the treatment of this disease. In addition autologous and allogenic hematopoietic stem cell transplantation can be taken into account in relapsed/refactory cases.
  • ||||||||||  Ruxience (rituximab-pvvr) / Pfizer, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Rituxan (rituximab) / Roche
    Trial completion date, Trial primary completion date:  19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) -  Dec 3, 2020   
    P1,  N=20, Recruiting, 
    To improve the efficacy of this recombinant immunotoxin, a phase I trial is underway in combination with rituximab to reduce tumor burden and decrease immunogenicity. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Zelboraf (vemurafenib) / Roche
    [VIRTUAL] High Multiplex Immune Profiling of the Bone Marrow Tumor Microenvironment Identifies Prognostic Biomarkers in Hairy Cell Leukemia (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_3730;    
    This is the first study to provide a high multiplex analysis of HCL BM microenvironment demonstrating significant immune dysregulation of the BM that does not recover with therapy and identify biomarkers of response to standard of care CDA. Prospective application of these biomarkers will allow early identification and increased monitoring/treatment in patients at increased relapse risk post CDA treatment.
  • ||||||||||  Leustatin (cladribine) / J&J, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Hairy Cell Leukemia in the Era of Targeted Therapy: A Case Presentation () -  Sep 14, 2020 - Abstract #SOHO2020SOHO_551;    
    Hairy cell Leukemia is a rare hematologic malignancy that can be confused with other indolent lymphoid malignancies. Current treatment is effective, but clinical trials are needed to develop best practices to offer patients with HCL a normal life expectancy.
  • ||||||||||  cladribine / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Hairy cell leukemia: present and future directions. (Pubmed Central) -  Sep 13, 2020   
    The anti-CD22 recombinant immunotoxin Moxetumomab Pasudotox can achieve MRD-negative CR in multiply relapsed HCL without chemotherapy toxicities and was FDA approved in 2018 as Lumoxiti. Investigational oral non-chemotherapy options also include Vemurafenib or Dabrafenib/Trametinib targeting BRAF V600E ± MEK, and Ibrutinib targeting Bruton's tyrosine kinase.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    FDA event, Preclinical, Review, Journal:  Moxetumomab pasudotox for hairy cell leukemia: preclinical development to FDA approval. (Pubmed Central) -  Sep 10, 2020   
    MP is generally well tolerated but has unique toxicities, including capillary leak syndrome and hemolytic uremic syndrome, which are poorly understood. This review will encompass the preclinical and clinical development of MP, with particular attention to its current indication in HCL.
  • ||||||||||  cladribine / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  The pharmacological management of hairy cell leukemia. (Pubmed Central) -  Sep 9, 2020   
    Patients in first relapse are also offered this combination if they were initially treated with a single-agent PNA, or if the remission duration was ≥5 years after first-line cladribine plus rituximab. Patients who relapse within 5 years are offered therapy with a novel agent that may include the BRAF inhibitor vemurafenib, alone or in combination with rituximab, dabrafenib in combination with trametinib, the BTK inhibitor ibrutinib, or moxetumomab pasudotox.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    [VIRTUAL] Industrial Biotechnology Award: Development and scale-up of the commercial fed batch refolding process for Lumoxiti, an anti-CD22 two chain immunotoxin (On Demand Oral) -  Aug 20, 2020 - Abstract #ACSFall2020ACS-Fall_2669;    
    Results from the 950L commercial scale refolding process are provided, demonstrating a greater than fivefold improvement in volumetric productivity compared to the clinical process. Lastly, several novel challenges that arose during late stage development are discussed including identification and control of low level expression of endogenous DE3 bacteriophage with a recA deficient E.coli host strain, as well as validation strategy for a process where the two polypeptide chains comprising Lumoxiti are expressed and recovered in separate fermentation unit operations.
  • ||||||||||  Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
    [VIRTUAL] Industrial Biotechnology Award: Development and scale-up of the commercial fed batch refolding process for Lumoxiti, an anti-CD22 two chain immunotoxin (Broadcast) -  Aug 20, 2020 - Abstract #ACSFall2020ACS-Fall_1282;    
    Results from the 950L commercial scale refolding process are provided, demonstrating a greater than fivefold improvement in volumetric productivity compared to the clinical process. Lastly, several novel challenges that arose during late stage development are discussed including identification and control of low level expression of endogenous DE3 bacteriophage with a recA deficient E.coli host strain, as well as validation strategy for a process where the two polypeptide chains comprising Lumoxiti are expressed and recovered in separate fermentation unit operations.